The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.
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The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.
The Articles of the Directive
The Articles of the Directive:
The effects of the directive
It is considered to have increased the costs of doing clinical trials in the EU, and to have caused the reduction in the number of such trials, especially of academic-led studies, and ones looking at new uses for old drugs. Germany derogated from the directive. It is due to be replaced by the EU Clinical Trials Regulation in 2016. The changes are due to come into effect in 2018.